BD Announces FDA 510(k) Clearance of Novel Molecular Assay to Diagnose C. diff Infections

BD Diagnostics, a segment of BD (Becton, Dickinson and Company), announced today it has received clearance from the U.S. Food and Drug Administration (FDA) to market the BD GeneOhm™ C. diff molecular assay for the rapid detection of the Toxin B gene found in toxigenic Clostridium difficile, the bacterial pathogen responsible for Clostridium difficile infection (CDI). It is the first CDI molecular diagnostic that offers sensitivity, simplicity and speed in one test procedure.

 “The BD GeneOhm Cdiff assay provides a simple and rapid stool test with excellent sensitivity and specificity that allows same-day identification of toxigenic Clostridium difficile,” said Thomas Davis, MD, PhD, professor of pathology and laboratory medicine at the Indiana University School of Medicine, and pathologist with Wishard Health Services and Clarian Health laboratories. “This test should improve patient care because it gives labs the option of a single assay that will markedly reduce or even eliminate the need for multiple screening and confirmatory tests. This would speed up reporting and help avoid unnecessary antibiotic use.”

In the United States, an estimated 500,000 people are infected annually, and more than 28,000 die from CDI. A recent national survey conducted by the Association for Professionals in Infection Control and Epidemiology (APIC) suggests that 13 out of every 1,000 hospitalized patients are suffering from CDI, and more than 7,000 patients in U.S. hospitals have CDI on any given day.  The average length of stay for a CDI patient is nearly three times longer than the typical patient, and CDI is estimated to lead to $1 billion in excess healthcare costs annually in the United States.  CDI rates continue to increase, driven by a new epidemic strain known as BI/NAP1/027, which has now been detected in at least 38 states, Canada and 14 European countries.

“CDI poses a significant challenge for healthcare facilities around the world,” said Jamie Condie, vice president and general manager of BD Diagnostics - Molecular Diagnostics. “The introduction of the BD GeneOhm Cdiff assay demonstrates BD’s ongoing commitment to develop a broad range of products to help prevent HAIs. BD provides molecular tests for key pathogens associated with HAIs, including Staphylococcus aureus, methicillin-resistant Staphylococcus aureus, vancomycin-resistant enterococci, and now Clostridium difficile.”

Cleared for the identification of toxigenic Clostridium difficile directly from stool specimens, the BD GeneOhm Cdiff assay targets the Toxin B gene, found in virtually all toxigenic Clostridium difficile strains, including the emerging BI/NAP1/027 epidemic strain. It is the only CDI molecular assay that combines high sensitivity and specificity and provides definitive test results in less than two hours. This new test may facilitate earlier and more appropriate antibiotic treatment of CDI patients. It may also lead to earlier implementation of infection control interventions that help prevent the transmission ofthe pathogen to other patients. Until now, diagnosing CDI rapidly has proven difficult. Traditional methods, including immunoassays, lack sufficient sensitivity, while tissue culture cytotoxicity methods are difficult to perform and require several days to yield results.

Source: BD